An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

NCT ID: NCT02325219

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-19
• Study Completion Date: 2019-02-08

Brief Summary

The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Detailed Description

A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.

Group Type: EXPERIMENTAL

CNTO 1959 50 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of CNTO 1959 50 mg.

Placebo 100 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Group 2

Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.

Group Type: EXPERIMENTAL

CTNO 1959 100 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of CNTO 1959 100 mg.

Placebo 50 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Group 3

Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.

Group Type: EXPERIMENTAL

CNTO 1959 50 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of CNTO 1959 50 mg.

CTNO 1959 100 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of CNTO 1959 100 mg.

Placebo 50 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Placebo 100 mg

Intervention Type: DRUG

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Interventions

CNTO 1959 50 mg

Participants will receive subcutaneous injection of CNTO 1959 50 mg.

Intervention Type: DRUG

CTNO 1959 100 mg

Participants will receive subcutaneous injection of CNTO 1959 100 mg.

Intervention Type: DRUG

Placebo 50 mg

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Intervention Type: DRUG

Placebo 100 mg

Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Intervention Type: DRUG

Other Intervention Names

Guselkumab; Guselkumab

Eligibility Criteria

Inclusion Criteria

• Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
• Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
• Have an IGA >= 3 at Screening and at Baseline
• Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
• Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)

Exclusion Criteria

• Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
• Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
• Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asahikawa, , Japan

Chūō, , Japan

Gifu, , Japan

Isehara, , Japan

Izumo, , Japan

Kanazawa, , Japan

Kawasaki, , Japan

Kita-Gun, , Japan

Kochi, , Japan

Kurume, , Japan

Kyoto, , Japan

Matsumoto, , Japan

Miyagi, , Japan

Morioka, , Japan

Nagoya, , Japan

Osaka, , Japan

Ōsaka-sayama, , Japan

Sapporo, , Japan

Shimotsuke, , Japan

Shinjuku-ku, , Japan

Tokushima, , Japan

Tokyo, , Japan

Tōon, , Japan

Tsu, , Japan

Tsukuba, , Japan

Ube, , Japan

Yokosuka, , Japan

Countries

Japan

Other Identifiers

CNTO1959PSO3004

Identifier Type: OTHER

Identifier Source: secondary_id

CR103833

Identifier Type: -

Identifier Source: org_study_id